Position: Sr. Manager
Department: Project Management and Biopharmaceutics

Qualifications:

• B. Pharm, M.Pharm, MSc

Experience:

• 10+ years

Vacancies: 01
Preferred: Immediate joiner
Location: Shivajinagar, Wakadewadi, Pune

Tasks and Responsibilities:

• Team Leadership: Lead the Bio-PK team to plan and execute BA/BE studies for various regulatory markets.
• PK Study Design: Manage the design of PK studies for demonstrating bioequivalence (BE) for solid, liquid, topical, and specialized dosage forms, including parental.
• Research and Writing: Conduct extensive literature searches, medical narrative writing, and summary report writing.
• Cross-functional Coordination: Coordinate with all cross-functional teams to support and develop clinical research projects.
• Pilot Study Review: Review and evaluate pilot bio-study clearance reports and results before initiating pivotal bio studies to ensure success.
• Protocol Development: Develop, review, and recommend scientifically supported PK study BE protocols for ANDAs.
• Study Report Review: Review draft and final BE study reports to ensure compliance with scientific and regulatory requirements.
• Medical Writing Management: Oversee and manage all medical writing activities.
• Client Support: Provide support to clients regarding CRO services.
• Risk Management: Proactively identify risks in ongoing studies and resolve issues in consultation with respective departments and sponsors.
• Document Preparation: Prepare service agreements and other confidential documents.
• Logistic Support: Ensure logistical support from sponsors.
• Regulatory Submission: Submit DCGI NOC documents to the office of DCGI for BA/BE study approval on time.
• Project Slotting: Coordinate with clinical operations and screening teams for project slotting.

Interested candidates can share their CVs at: careers@synergenbio.com

AD